Select Agent & Toxin Program Compliance Checklist [FREE PDF]
This select agent program compliance checklist verifies entities possessing CDC/USDA select agents and toxins comply with 42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121 regulations. Responsible Officials (ROs) use this to assess program compliance between mandatory federal inspections.
- Industry: Laboratory
- Frequency: Semi-Annually
- Estimated Time: 45-60 minutes
- Role: Responsible Official (RO) / Alternate Responsible Official
- Total Items: 8
- Compliance: 42 CFR Part 73 (select agents and toxins - HHS), 7 CFR Part 331 (USDA plant protection select agents), 9 CFR Part 121 (USDA veterinary select agents), FSAP (Federal Select Agent Program) inspection criteria
Inventory & Security
Verify select agent inventory and security controls.
- Select agent inventory current with all transfers, acquisitions, and destructions documented?
- Select agents stored in approved, locked containers within secure areas?
- Access to select agents limited to approved individuals only?
- No transfers or acquisitions outside of FSAP approval?
Incidents & Training
Verify incident reporting and training compliance.
- Select agent incident and theft/loss reporting procedure documented?
- All approved personnel current on select agent safety training?
- Biosecurity plan current and reviewed annually?
- Select agent program compliance notes
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Why Use This Select Agent & Toxin Program Compliance Checklist [FREE PDF]?
This select agent & toxin program compliance checklist [free pdf] helps laboratory teams maintain compliance and operational excellence. Designed for responsible official (ro) / alternate responsible official professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: semi-annually.
Ensures compliance with 42 CFR Part 73 (select agents and toxins - HHS), 7 CFR Part 331 (USDA plant protection select agents), 9 CFR Part 121 (USDA veterinary select agents), FSAP (Federal Select Agent Program) inspection criteria. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Select Agent & Toxin Program Compliance Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Inventory & Security, Incidents & Training. It is designed for laboratory operations and compliance.
How often should this checklist be completed?
This checklist should be completed semi-annually. Each completion takes approximately 45-60 minutes.
Who should use this Select Agent & Toxin Program Compliance Checklist [FREE PDF]?
This checklist is designed for Responsible Official (RO) / Alternate Responsible Official professionals in the laboratory industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.